Salesforce Inc Jobs in Olney

About the Role

Kolon TissueGene, Inc. is seeking an Associate Director, Clinical Quality Assurance responsible for maintaining the Quality Management System and other programs to support Clinical Operations and commercialization of biopharmaceutical products. This role will ensure that all Clinical QA details are managed efficiently and exhibit continuous improvement.

Reporting to the Head of Quality Assurance, this role will support Inspection Readiness, regulatory Inspections, Quality policies and procedures. The Associate Director, Quality Assurance will work with Clinical Operations and Regulatory Affairs to ensure adherence to KTG policies, programs, and procedures in support of commercialization. A fundamental measure of success for the position will be a successful BLA Approval Inspection and launch of commercialized drug products.

This position is based on-site at our Rockville, Maryland headquarters.

Key Responsibilities

Quality Systems Leadership

• Lead the implementation, maintenance, and continuous improvement of the Quality Management System (QMS), including Change Control, Deviations, Complaints, Vendor Management, and Audit programs.
• Ensure quality processes and systems meet FDA and global regulatory expectations.
• Oversee electronic quality systems supporting training management and GxP document control.

Clinical Quality Oversight

• Drive the GCP Quality strategy across clinical development programs.
• Provide independent Quality oversight of Clinical Operations to ensure compliance with regulatory and internal quality requirements.
• Review and approve clinical and nonclinical documentation, including protocols, amendments, deviations, CAPAs, and change controls.
• Oversee the development and maintenance of Clinical SOPs.
• Manage training qualification and compliance for Clinical Operations and Data Management teams.

Inspection Readiness & Regulatory Support

• Lead inspection readiness activities across clinical programs.
• Serve as a lead representative during FDA inspections and vendor audits.
• Support regulatory interactions including GCP inspections, Pre-Approval/BLA inspections, and investigator site inspections.
• Ensure clinical programs maintain inspection-ready documentation and processes.

Risk Management & Continuous Improvement

• Lead quality risk management initiatives, facilitating risk assessments and implementing mitigation strategies.
• Identify opportunities for process improvements and quality system enhancements.
• Ensure quality initiatives and projects are properly resourced and executed within established timelines.

Leadership & Team Development

• Build and lead a high-performing Clinical QA team.
• Manage hiring, coaching, and development of Quality staff.
• Promote a culture of quality, compliance, and “first-time-right” execution.
• Ensure team members maintain appropriate training and qualifications.

Operational & Strategic Support

• Develop and manage Quality department timelines, budgets, and resource planning.
• Provide regular updates to senior leadership and project teams regarding Clinical QA activities and inspection readiness.
• Manage Quality vendor relationships and contracts, including quality consultants and electronic quality system providers.

Qualifications

Education

• Bachelor’s degree in Biological Sciences, Life Sciences, Physical Sciences, or a related discipline required
• Advanced degree (M.S., Ph.D., or equivalent) preferred

Experience

• 10+ years of experience in the biopharmaceutical industry, with a minimum of 8 years demonstrated experience of direct interaction with FDA and other regulatory agencies through GCP, Pre-Approval/BLA Inspections, and Investigator Site inspections.
• 6+ years of leadership experience in Clinical Quality Assurance roles
• Experience developing, implementing, and maintaining Quality Management Systems (QMS)
• Experience working with Clinical Operations and Regulatory Affairs teams in regulated development environments
• Experience in cell and gene therapy programs or advanced biologics preferred

Core Competencies

• Strong knowledge of ICH guidelines, FDA regulations, and GCP compliance requirements
• Expertise in Quality Management Systems, including change control, deviations, CAPA, audits, and vendor oversight
• Ability to maintain independent Quality oversight of Clinical Operations
• Strong leadership, organizational, and team development skills
• Excellent written and verbal communication skills
• Strong problem-solving and risk management capabilities
• Demonstrated commitment to quality, compliance, and continuous improvement

Work Environment & Physical Requirements

• On-site position with up to approximately 20% travel.
• Extensive computer and keyboard use involving repetitive motion.
• Regular telephone and in-person communication.
• Ability to lift up to 25 pounds, with or without reasonable accommodation.

Kolon TissueGene will provide reasonable accommodations for qualified individuals with disabilities in accordance with the Americans with Disabilities Act (ADA) and applicable state law.

Why Join Kolon TissueGene?

Kolon TissueGene is advancing innovative regenerative cell and gene therapies designed to address the root causes of disease. As a member of our Bioinformatics team, you will contribute directly to the scientific rigor and data integrity that enable safe, effective therapies to reach patients.

About Us

Kolon TissueGene, Inc. (KTG) is a clinical-stage biopharmaceutical company developing first-in-class regenerative therapies, including TG-C for osteoarthritis of the knee. We are building a mission-driven team committed to scientific excellence, regulatory compliance, and patient impact.

Benefits Highlights:

• Onsite yet Flexible work schedules
• Premium-free global health insurance (50% dependent coverage)
• 401(k) with immediate eligibility
• Long-term incentive bonuses
• On-site gym & wellness perks
• Extra PTO accrual every year
• Global and local training opportunities
• Visa sponsorship available for qualified candidates

Equal Opportunity Employer

Kolon TissueGene, Inc. is proud to be an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration without regard to race, color, religion, gender, identity, sexual orientation, national origin, disability, or veteran status.

Apply today to shape the future of regenerative medicine with precision, rigor, and purpos

Berkel & Company Contractors, Inc. is seeking a Survey Technician for our regional office located in Silver Spring, MD. This field-based position will support projects related to Auger Pressure Grouted Piling, Displacement Piling, Driven Piling, Pressure Grouting, Sheeting and Shoring, Ground Improvement and Micro Piling located across the Mid-Atlantic. This position ensures all required layout and as-builts for a given project are performed accurately and promptly to support Berkel’s ongoing projects. Our survey technicians are expected to have competent technical knowledge and strong attention to detail.

This position offers the opportunity for growth into quality control supervisory roles.

Responsibilities include, but are not limited to:

• Compute coordinates for use in layout.
• Perform field layout and as-builts.
• Preparation of detailed as-built reports.
• Coordinate with project managers and superintendents to ensure accurate and timely completion of survey tasks.
• Perform analysis of survey data and assist in the resolution of any discrepancies in measurements or documentation.
• Review and cross checking of shop drawings and contract drawings, including but not limited to structural, architectural, and civil drawings.

Qualifications:

• Bachelor’s or Associate’s degree in a technical field preferred.
• Professional Land Surveying License preferred but not required.
• 2+ years’ experience as a Survey Technician or in a similar role.
• Experience in preparing survey documents and conducting fieldwork.
• Experience with industry software, including but not limited to, AutoCAD, Revit, Bluebeam, and Microsoft Office programs.
• Ability to utilize survey equipment and technology effectively.

Compensation:

• Based on experience.

EOE/Minorities/Females/Veterans/Disability (Compliant with the new VEVRAA and Section 503 rules)

Job Description:

The Facility / Building Engineer is responsible for the daily operation, maintenance, and repair of building systems to ensure safe, reliable, and efficient facility operations. This role supports the performance and longevity of HVAC, electrical, plumbing, and mechanical systems while responding to service requests and maintaining compliance with safety standards.

This position is ideal for a hands-on professional with strong troubleshooting skills and experience supporting commercial facilities.

Essential Functions:

·       Operate, monitor, maintain, and repair building systems including HVAC, plumbing, electrical, and mechanical equipment

·       Perform preventative maintenance and corrective repairs as scheduled or needed

·       Respond to service requests and emergency maintenance issues in a timely manner

·       Conduct regular inspections of building systems and equipment

·       Maintain maintenance logs, work orders, and compliance documentation

·       Coordinate with external vendors and contractors for specialized repairs or services

·       Ensure compliance with safety policies, local codes, and regulatory requirements

·       Support facility improvements, upgrades, and special projects as assigned

·       Maintain a clean, safe, and organized work environment

Qualifications and Education:

·       Prior experience as a building engineer, facility technician, or similar role

·       Working knowledge of HVAC, electrical, plumbing, and mechanical systems

·       EPA Universal Certification or other relevant certifications preferred

·       Strong troubleshooting, problem-solving, and communication skills

·       Ability to work independently and prioritize multiple tasks

What We Offer:

·       Holaday-Parks, Inc., offers an excellent salary and benefits package—paying 100% of medical/vision/dental, and prescription premiums for employees.

Pay Range:

·       $34-$45 DOE, hourly

If interested in applying, please submit your cover letter and resume to  

Holaday Parks is an Equal Opportunity Employer (EOE), including protected veterans and people with disabilities

Job Title: Customer Success Manager

Location: US - Remote

OptymEdge is advancing global ophthalmology clinical trials through the Acuvera Suite-Certify, Capture, and Imaging-bringing digital transformation to visual function endpoints. To support this growth, we are seeking a Customer Success & Strategic Growth Manager to support and execute value realization, strengthen sponsor and CRO partnerships, and unlock long-term account expansion.

Primary Purpose

This client-facing role blends customer success, strategic account management, and commercial insight. You will partner with key global sponsors, oversee engagement across the customer lifecycle, and convert operational excellence into deeper, multi-service relationships. You will also contribute to the development of scalable CS frameworks that support OptymEdge's growth trajectory.

1. Strategic Account Leadership

* Serve as the primary point of contact for assigned strategic accounts

* Lead onboarding, adoption, and continuous value delivery across Certify, Capture, and Imaging modules

* Conduct structured governance meetings, QBRs, and planning sessions with client stakeholders

* Build multi-level, trust-based relationships anchored in scientific credibility and shared goals

* Identify risks early and drive cross-functional resolution to maintain delivery excellence

2. Growth & Expansion Opportunities

* Identify upsell, cross-sell, and multi-service expansion opportunities in partnership with Commercial and Business Development teams

* Contribute to the development of long-term partnership and account growth strategies

* Partner with Business Development on renewals, pricing input, and proposal development

* Track and report NRR, account health indicators, and expansion pipeline activity

3. Cross-Functional Partnership

* Collaborate with Delivery, Clinical, Product, Technology, and Marketing teams to ensure consistent execution

* Translate customer insights into actionable product and service improvement recommendations

* Contribute to value stories, case studies, and customer success narratives

* Serve as the internal voice of the customer to support alignment across teams

4. Operational Excellence & Scaling

* Contribute to the development and refinement of scalable CS processes, playbooks, and engagement frameworks

* Build and maintain account health models and standardized reporting dashboards

* Leverage CRM and analytics tools for forecasting, engagement tracking, and risk signaling

* Support knowledge sharing and onboarding activities as the CS function grows

* Bachelor's/Master's in Life Sciences, Business, or related field.

* 5+ years in customer success, strategic account management, or clinical operations.

* Experience with eClinical or digital health systems.

* Strong communication, stakeholder management, and commercial awareness

Bonus Points

* Experience in ophthalmology clinical research or endpoint services

* Familiarity with eSource, imaging, or certification platforms

* Experience in growth-stage or transformation-focused organizations

* Proficiency with Salesforce or similar CRM platforms

Emmes Group: Building a better future for us all.

OptymEdge is part of the The Emmes Group. Emmes is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. Emmes Group was founded as Emmes more than 47 years ago, becoming one of the primary clinical research providers to the US government before expanding into public-private partnerships and commercial biopharma. Emmes has built industry leading capabilities in cell and gene therapy, vaccines and infectious diseases, ophthalmology, rare diseases, and neuroscience.

We believe the work we do will have a direct impact on patients' lives and act accordingly. We strive to build a collaborative culture at the intersection of being a performance and people driven company. We're looking for talented professionals eager to help advance clinical research as we work to embed innovation into the fabric of our company. If you share our motivations and passion in research, come join us!

Why work at Emmes?

At Emmes, your actions and hard work will have a direct impact on public health initiatives, both globally and in our local communities with opportunities for volunteerism through our Emmes Cares community engagement program. We offer a competitive benefits package focused on the health and needs of our growing workforce, including:

• Flexible Approved Time Off

• Tuition Reimbursement

• 401k Retirement Plan

• Work From Home Anywhere in the US

• Maternal/Paternal Leave

• Casual Dress Code & Work Environment

CONNECT WITH US!

Follow us on Twitter - @EmmesCRO

Find us on LinkedIn - Emmes

The Emmes Company, LLC is an equal opportunity employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to disability or protected veteran status.

#LI-Remote

Benefits medical, dental, vision, 401K, life insurance, strong safety culture, and much more!  Excellent local leadership.

US Foods is one of the largest food distributors with a culture and history of promoting from within, excellent training programs and a continuous improvement focus. 

Main Ingredients of the Job

• Safely drive trucks to customers and meet scheduled customer delivery times

• Carefully unload products from the trailer with a two-wheeler, pallet jack, or by hand and place in designated customer storage areas

• Verify accuracy of delivery with customers and obtain proper signatures

• Handle collections and payments from customers when applicable

• Professionally perform customer service responsibilities to enhance our client experience

• Perform all pre-trip and post-trip equipment inspection

Physical Requirements

• Ability to lift/carry/push/pull 20 to 80+ lbs. of product repetitively during each shift required

• Comfortable driving and working in inclement weather conditions with frequent stops (10+ per shift) required

What You Bring to the Table

• Register to the FMCSA Clearinghouse*

• Must be at least 21 years of age

• Must have valid CDL Class A issued by the state of legal residence with necessary endorsements and DOT qualifications

• Minimum of six months commercial driving experience (any industry) OR three months commercial driving experience in the food and/or beverage delivery industry required

• Ability to operate manual transmission preferred; may be required in specific locations

• Must be able to read and communicate in the English language - able to hold a conversation, to understand highway traffic signs and signals, to respond to official inquiries,  and to enter information on reports and records.

Why US Foods

US Foods®  helps our customers Make It, with products and services that shape the communities where we live and work. Opportunities in our company abound for skilled, forward-thinking associates.

Great drivers are crucial to the US Foods® team and one of the important faces of our organization. On and off the road, our drivers strive for integrity and reliability, while building trusting relationships with customers.

At the foundation of those efforts are our cultural beliefs, the pillars that define our work ethic, collaborative spirit and service. Together we help our customers make it, but we also believe in helping our drivers make it!

At US Foods®, we are committed to Total Rewards that respect and reward our associates for their dedication and hard work.

*Registering to the FMCSA Clearinghouse is a requirement by the Department of Transportation. All Drivers are required to the Clearinghouse website and register to the new database. The Clearinghouse is a secure online database that provides real-time information about commercial driver’s license (CDL) and commercial learner’s permit (CLP) holders’ drug and alcohol program violations. If you have not registered to the FMCSA database, please note registration is required. Please visit and click GO to login. If you are able to log into login, but are having trouble with the Clearinghouse registration, see “Clearinghouse Help” field on the clearinghouse page.

Compensation depends on relevant experience and/or education, specific skills, function, geographic location, and other factors as applicable by law. The expected rate for this role is between $70,000 and $150,000 annually.

As applicable, this role will also receive overtime compensation, retention bonus, component pay based on cases, mileage, stops, etc.

Benefits for this role may include health insurance, pre-tax spending accounts, retirement benefits, paid time off, employee stock purchase plan, and life insurance

We have outstanding contract positions for HR Specialists I & II to join a leading organization located in the Silver Spring, MD area. To be considered for this role, you must have Federal Agency HR experience.

**Candidates must have the ability to obtain and maintain a Public Trust.**

Job Responsibilities:

-Perform work using FDA systems access to USA Staffing to complete the following phases:

• Pre-consultation
• Announcement Drafting
• Announcement Posting
• Qualifications Review
• Certificate Issuance
• Onboarding

-Schedule and conduct pre-consultation meetings with the Center, Offices and Programs.

-Prepare job analysis, specialized experience statement, and assessment questions.

-Write clear, informative streamlined job opportunity announcements (JOAs).

-Post vacancy announcements on USAJOBS in accordance with standard operating procedures.

-Process all applications received through automated system.

-Verify candidates' claims of eligibility under the Career Transition Assistance Plan (CTAP) and Interagency Career Transition Assistance Plan (ICTAP).

-Provide status notifications to all applicants at the key touch points in the application process (application received, application assessed for qualifications, and application referred/not referred) and respond to applicant inquiries.

-Review applications to determine basic eligibility / minimum qualification requirements by closely reviewing the candidates' supporting documentation (i.e., resumes and/or transcripts).

-Support issuance of competitive, merit promotion, excepted service, and/or noncompetitive certificates/referral lists electronically in accordance with merit system principles and delegated examining procedures.

• Review complete Delegated Examining Unit (DEU) recruitment actions, documentation and adjudicate veterans' preference prior to assignment of preference on the final referral list (DEU certification required).
• Ensure compliance and provide advice and guidance the Selecting Official on regulations, policies and procedures involving selections from the Certificate of Eligibility, which includes, but is not limited to, veterans' implications and displaced employees.
• Conduct quality review for all recruitment products, i.e., ensure that all job analysis, vacancy announcements questionnaires, qualification determinations, certificates of eligibility, etc., are accurate and based on appropriate OPM, HHS, and FDA policies and regulations prior to issuance of job offer letter.
• Support selectee initial job offer notification after return of certificate of eligibility from selecting official and propose salary level, including special pay/incentives, in accordance with OPM and FDA guidelines.
• Coordinate notification to the selected candidate regarding any pre-appointment requirements and their entrance on-duty date.
• Audit returned certificates and send disposition notices to non-selected candidates.
• Maintain examining case file, including job analysis documentation, in accordance with an agency's records retention schedule.
• Answer applicant phone calls and written correspondence and rating appeals related to the staffing services provided.
• Respond to inquiries from agency stakeholders regarding staffing actions.

Basic Hiring Criteria:

HR Specialist I (Payrate: $32-35/hour)

• Bachelor's Degree.
• 3 years of verifiable Federal Agency HR experience

HR Specialist II (Payrate $39 - $41/hr)

• Bachelor's Degree.
• 5 years of verifiable Federal Agency HR experience

Our client - the Mayberg Foundation - is a private family foundation dedicated to investing in organizations and initiatives with bold ideas that inspire, educate, and strengthen Jewish community locally, nationally, and globally. Due to continuing program growth, they are expanding their leadership team and hiring a Director of Operations to oversee the Foundation’s internal operations and ensure alignment across key functional areas, including finance, HR, IT, facilities, and compliance.

Guided by a strong sense of mission to play a critical strategic and coordinating role that will impact the direction and generational longevity of the Foundation and its grantmaking mission, the Director of Operations will leverage a team of trusted consultants and internal staff while focusing on systems, supervision, and alignment. You will delegate effectively, use existing resources wisely, and drive continuous improvement and cross- functional coordination. As a leader in a mission driven organization, you will also integrate the vision and values of the Foundation into decision making and contribute to a culture that reflects and advances the Foundation’s commitment to proliferating Jewish wisdom and values. This position reports to the Executive Director.

This is a full-time, in-office position offering a competitive salary and excellent benefits, including 100% employer-paid medical for the employee and a 401K with up to 10% employer contribution.

Key Responsibilities:

Operations Leadership

• Serve as a strategic partner to the Executive Director and Director of Strategic Grantmaking, ensuring cohesive coordination across all operational functions in support of the Foundation’s mission
• Lead operational planning and support for Board meetings, staff retreats, and major organizational events ensuring these are aligned with and advance the Foundation’s vision
• Model and uphold the Foundation’s values, professionalism, and commitment to its mission in all internal and external activities, processes, and policies
• Perform other duties as needed in support of the Foundation’s operational success and its broader purpose.

Business Operations and Systems

• Provide strategic oversight and quality control, including identify opportunities for improvements, for core operational functions, including finance, human resources, grant administration and technology, ensuring alignment with organizational goals, mission and compliance standards
• Supervise and collaborate with Foundation staff and partners (e.g. Accountant, HR Consultant, IT Vendors) and manage relationships in ways that reflect the Foundation’s values and commitment to mission-driven work
• Oversee budgeting, forecasting, financial reporting, and audits in collaboration with finance partners; supervise compliance with nonprofit accounting standards and financial policies, including IRS regulations; present financial reports for internal use and Board review that support strategic decisions aligned with the Foundation’s mission
• Support effective recruitment, onboarding, performance management, and staff development efforts in partnership with HR consultant; promote a positive, mission-driven and inclusive workplace culture
• Ensure accurate payroll, benefits administration, employee records, and compliance with employment laws and internal HR policies
• Direct the maintenance and security of technology systems and data platforms (e.g. CRM, grant management, file storage); coordinate with IT partners on troubleshooting, upgrades, and cybersecurity
• Oversee grant administration workflows by aligning program, finance, and administrative processes- track signed agreements, coordinate disbursements, and supervise calendars for key deadlines and compliance documentation in ways that align appropriate with the culture of the Foundation and its grantee-clients

Office & Facilities Management

• Provide strategic oversight of the office and facilities operations, ensuring high standards for cleanliness, safety, functionality, hospitality, and an environment that reflects the Foundation’s values.
• Supervise and support the Office Manager in the day-to-day administration of the Foundation’s physical office including office maintenance, vendor coordination, and share space management, and serve as a backup or point of escalation when needed to ensure continuity of operations
• Oversee office infrastructure and equipment, partnering with IT consultants to ensure systems are current, secure, fully functional and supportive of the Foundation’s core work and staff needs
• Maintain, ensure, and implement office procedures, safety protocols, emergency response plans, and up-to-date physical security systems
• Oversee logistics and quality control for internal and vendor-supported events, supervising event staff as appropriate and ensuring cultural and mission focused details are addressed

Compliance & Risk Management

• Monitor and manage organizational compliance requirements, including IRS filings, state registrations, and charitable filings in service of the Foundation’s integrity and accountability
• Maintain lay governance documents such as bylaws, meeting minutes, and board policies
• Coordinate annual compliance processes, including D&O insurance renewals
• Support risk mitigation efforts across all operational areas, identifying and addressing potential vulnerabilities
• Ensure adherence to document retention, archiving protocols, and internal control policies

Qualifications

• BA/BS required; Master’s degree preferred
• Experience and familiarity with Jewish communal organizations
• Minimum 7-10 years of relevant professional experience
• Working knowledge of finance, budgeting, and accounting practices
• Experience overseeing HR functions, including compliance, the employee experience, and policy development.
• Exceptional organizational and project management skills; ability to manage multiple priorities and meet deadlines
• Excellent interpersonal and communication skills, with the ability to work collaboratively across departments and with external partners
• Discretion and sound judgement in handling confidential and sensitive matters
• Detail oriented, proactive, and resourceful, with a continuous improvement mindset
• Proficiency in the use of professional technology including MS Office Suite (Word, Excel, PowerPoint, and Outlook). Professional familiarity/experience with social media.